There are three main types of packaging – primary, secondary, and tertiary – and it is important to understand that all levels of packaging serve specific purposes with specific requirements, in order to get products to people safely, efficiently, and consistently. Primary packaging is what directly encases and contains the drug product. Secondary packaging is the exterior packaging of the primary packaging that groups packages and further protects or labels the drug product. Tertiary packaging is used for bulk handling, storage, and distribution. An example of these packaging levels in the pharmaceutical industry are a vial or blister (primary packaging) placed into a carton (secondary packaging), then packed into a shipping case (tertiary packaging). This article will focus on secondary packaging and the importance of selecting a supplier who is well equipped to handle a product’s unique and customized packaging needs.  

Name:Scott Reed

Alcami Site: Charleston, SC 

What is your role? 
I am a manufacturing technician with a focus on compounding and filling.

How long have you been with Alcami?
I have been with Alcami since June of 2018.

What is the most rewarding part of your job? 
The most rewarding parts of my job are taking a product from start to finish, and knowing that I had a direct part in improving the quality of life for others. 

Alcami will be exhibiting at AAPS 2019 PharmSci 360, to be held November 3 - 6 in San Antonio, Texas. Schedule a meeting or stop by booth #1511 to connect with our team.

Alcami will be exhibiting at CPhI Worldwide, to be held November 5 - 7 in Frankfurt, Germany. Schedule a meeting or stop by booth #121C31 to connect with our team.

Durham, NC (USA) – October 8, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today announced the launch of its new rapid sterility offering, a service that leverages cutting-edge microbiological testing technology to deliver significantly faster testing results to clients. Alcami invested in the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami is launching rapid sterility via the Milliflex^® Rapid System, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days. A fully comprehensive comparability study verifies adherence to USP/Ph.Eur. requirements for alternative microbiological methods and demonstrates that rapid sterility is a reliable alternative to the reference method.

In this webinar, Alcami’s rapid sterility expert, Stacey Ramsey, will introduce Alcami’s new rapid sterility platform and provide information for understanding implementation requirements. Stacey will also discuss the advantages of the rapid sterility platform as it compares to USP <71>. 

Dr. Imran Ahmed, Head of Formulation Development at Alcami, recently published an article in Pharma Tech Outlook. The article, The Changing R&D Landscape: Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs), explains that as a result of pharmaceutical products becoming increasingly complex, new regulatory and manufacturing challenges are on the rise.

Excerpt from Ahmed: "The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. After a precipitous fall in new drug approvals during the last two decade of the 20th century, there has been a gradual recovery going into the second decade of the 21st century."

Name: Arne Van Mol

Alcami Site: Weert, Netherlands

What is your role? 
I am a process engineer at the Alcami site in Weert, Netherlands. My role is to scale up manufacturing activities in accordance with environmental, health and safety (EH&S) and current good manufacturing practice (CGMP) requirements.

How long have you been with Alcami?
My first experience with Alcami was during my internship in 2017. I had the pleasure of supporting the scale up of an active pharmaceutical ingredient (API) starting from a 2L reactor (150 grams of API) to a 400L reactor (36 kilograms of API).

I rejoined the Alcami team in November 2018 as a full-time employee.

What is the most rewarding part of your job? 
Working closely with R&D chemists in order to solve scale up obstacles and technical issues, such as emulsified phase separations or poor conversions, is the most satisfying part of the job.

Alcami recently contributed to a special feature in The Medicine Maker magazine, titled "How to Find Your Secret Source."

Excerpt from Alcami: “I have a point of contention with the titles  ‘one-stop shop' or 'specialist supply chain’ because they imply that you can’t have both! If you have independent API and drug product, you can bring these together. Being that we were founded by merging two specialized organizations, we have experts in each area, which we then over arch with a structured offering to make sure they are properly integrated. A key thing our clients tell us – especially smaller clients who don’t want to manage a big supply chain – is that they like the internal efficiencies you can get with a one-stop shop."

Alcami recently contributed to a special feature in the August / September issue of Chemicals Knowledge magazine, titled "Considerations for Approval of Biosimilars."

Biosimilars are sometimes incorrectly considered equivalent to a generic small molecule therapeutic, but for a biologic drug product, the clinical and regulatory pathways are quite different. Alcami Commercial Development Manager Cheryl Johnson explains the distinct differences in the FDA’s definition, development strategy, and regulatory approval pathways.